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ISRCTN
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ISRCTN69567857
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ClinicalTrials.gov identifier
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Public title
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Determination of quality of life instrument most preferred by head and neck patients
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Scientific title
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Determination of quality of life instrument most preferred by head and neck patients: a multicentre randomised controlled trial
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Acronym
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DETERMIN
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Serial number at source
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HM22-0806
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Study hypothesis
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This research project is to identify head and neck cancer patients most preferred questionnaire that will help them communicate and describe problems more effectively with their doctor. The null hypothesis is that the four questionnaires are equally useful in facilitating the communication of health concerns of both laryngeal and oral cancer patients to their health professionals.
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Ethics approval
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Coventry Local Research Ethics Committee approved on the 13th December 2006 (ref: 06/Q2802/101)
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Study design
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Multicentre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Early and advanced oral and laryngeal cancer
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Participants - inclusion criteria
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1. Patients aged greater than 18 years, either sex
2. Diagnosed with oral or laryngeal cancer
3. Attending the head and neck cancer clinic at least 3 months after completion of treatment
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Participants - exclusion criteria
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1. Patients who do not have oral or laryngeal cancer
2. Patients who have known recurrence of cancer
3. Patients who are undergoing palliative treatment
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Anticipated start date
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21/10/2008
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Anticipated end date
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29/10/2010
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Status of trial
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Ongoing |
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Patient information material
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Can be found at http://www.inhanse.org
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Target number of participants
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600 returned questionnaires
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Interventions
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Four questionnaires will be randomised in each pack. Packs are colour coded regarding early or advanced oral or laryngeal cancer. Patients are asked to complete study instrument in clinic while waiting to see their clinicians.
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Primary outcome measure(s)
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To determine which of four most commonly used head and neck health related quality of life instruments oral and laryngeal cancer patients find most helpful in facilitating communication of their health problems to their clinicians, measured in December 2010.
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Secondary outcome measure(s)
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To determine the clinical significance of reported health related quality of life changes detected by the commonly used quality of life instruments in head and neck cancer, measured in December 2010.
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Sources of funding
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Macmillan Cancer Support (UK)
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Trial website
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http://www.inhanse.org
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Publications
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Contact name
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Prof
Hisahm
Mehanna
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Address
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InHANE offices OPP ward 32
3rd Floor West Wing
University Hospitals Coventry and Warwickshire NHS Trust
Clifford Bridge Road
Walsgrave
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City/town
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Coventry
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Zip/Postcode
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CV2 2DX
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Country
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United Kingdom
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Tel
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+44 (0)24 76 96 5244
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Fax
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+44 (0)24 76 96 6915
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Email
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hisham.mehanna@uhcw.nhs.uk
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Sponsor
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University Hospitals Coventry and Warwickshire NHS Trust (UK)
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Address
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c/o Ceri Jones
Research and Development Service Manager
University Office Suite, 1st Floor Retunda
Clifford Bridge Road
Walsgrave
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City/town
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Coventry
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Zip/Postcode
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CV6 4GJ
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Country
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United Kingdom
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Sponsor website:
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http://www.uhcw.nhs.uk
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Date applied
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09/07/2010
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Last edited
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21/07/2010
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Date ISRCTN assigned
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21/07/2010
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